DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Response to Arguments
Applicant's arguments filed 0 have been fully considered but they are not persuasive.
Regarding arguments presented on the remarks dated 09/29/2025, it is stated that Raymond does not teach a sensor and/or estimation pipeline, Examiner states that Zickler was used to teach the sensor. Said sensor was disclosed in [0051]-[0052] of Zickler. An estimation of diffractive power addition was argued to be taught in Raymond, where an aberrometer to sense aberrations in [0038] with a characterization of an error in [0025]. Raymond was not relied upon to teach the act of adding a diffractive power, as the laser pulses applied to the IOL was taught by a different reference (being Zicker). Raymond was relied upon to teach an estimation of a power addition. Regarding the arguments about Zicker in view of Raymond and Dia not being an appropriate rejection as Raymond and Dia are directed for use before an implantation, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, examiner argues that Zicker is used to teach the limitation that a writing occurs before an implantation, while Raymond and Dai are used to teach other aspects of a procedure independent to the timing of the procedure. As Raymond and Dai are modifying the procedure of Zicker with a provided motivation in the prior action, Raymond and Dai are seen as being combinable with the procedure of Zicker. Raymond is not used to teach a treatment of an intraocular lens after an implantation of an eye but used to teach an evaluation of a spherical error of an eye. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Raymond into Zickler to provide a pre-treatment evaluation of a patient that the controller of Zickler (controller in [0008]-[0010] of Zickler) can use to control the laser application (use of sensed values for a control in [0052] of Raymond).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6 and 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zickler (US Pub No.: 2010/0082017) in view of Raymond (US Pub No.: 2016/0150952) and Dai (US Patent No.: 7,931,371).
Regarding claim 1, Zickler (US Pub No.: 2010/0082017) discloses a method for improving vision of a subject, the method comprising, receiving, via a control system comprising a sensor (being the sensor in [0051]-[0052], wherein the sensor system consists of this, the imaging interface, and image processor in [0051]), applying a plurality of laser pulses to an intraocular lens IOL (in the abstract), the laser pulses being configured to produce, by refractive index writing on the IOL, the estimated diffractive power addition to partially or fully correct the non-zero physical error (a laser beam to produce “the corrected refractive profile” is disclosed in the abstract. Here, while physical error correction is not specifically disclosed, a correcting of a refractive profile corrects a physical error, and the disclosed laser will correct physical errors in the eye of a user), wherein the applying the plurality of laser pulses to the IOL to produce the estimated diffractive power addition is performed after the IOL is implanted in an eye of the subject (the laser is applied to the eye in [0054], where the eye has an intraocular lens 30 as per [0054]-[0055]).
However, Zickler does not teach that a non-zero residual spherical error that requires an estimated diffractive power addition in the IOL, or receiving, via a control system comprising a sensor, an estimated diffractive power addition to partially or fully correct for a non-zero residual spherical error .
Instead, Raymond (US Pub No.: 2016/0150952) discloses a non-zero residual spherical error that requires an estimated power addition in the IOL (in [0025], spherical error characterization is used for a pre-treatment of an intraocular lens, with IOLs further detailed in [0019]) and receiving, via a control system comprising a sensor (aberrometer sensing disclosed in [0030] and [0038], with [0030] disclosing a processor to derive a treatment vector), an estimated diffractive power addition to partially or fully correct for a non-zero residual spherical error (in [0038], the aberrometer sensing is disclosed to sense aberrations via a sensing of a topography of an eye, with pre-treatment aberration measurements being used to characterize a spherical error as per [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the spherical error characterization of Raymond into Zickler to provide a pre-treatment evaluation of a patient that the controller of Zickler (controller in [0008]-[0010]) can use to control the laser application (use of sensed values for a control in [0052] of Raymond).
With the teachings of Raymond incorporated into Zickler, Zickler in view of Raymond teaches a non-zero spherical error that requires an estimated diffractive power addition in the IOL (As mentioned above in Raymond, in [0025], spherical error characterization is used for a pre-treatment of an intraocular lens. From here, as per [0060] of Zickler, the IOL also includes a mask that includes a diffractive surface that provides a low add in power and as the laser modifies “desired subsurface regions of the intraocular lens” in [0053] of Zickler, Zickler is capable of modifying the diffractive mask via a treatment laser. Here, a wavefront aberrometer for evaluating an eye, described in [0030] of Raymond with more details in [0205], determines aberrations in the eye to which the laser system that acts on a diffractive mask of Zickler in response to said aberrations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the power estimation of Raymond into the device of Zickler as the power addition determination as presented within Raymond provides a means to determine if a power addition is required for the diffractive mask in Zickler and then allows the laser treatment of Zickler to act upon the mask of Zickler, as well as the rest of the intraocular lens of Zickler, to impart said power addition determined by the aberrometer in paragraph [0030] of Raymond.
From here, Zickler in view of Raymond does not teach an instance wherein the sensor is configured to measure the non-zero residual spherical error, and wherein the non-zero residual spherical error comprises a non-zero physical error.
Instead, Dai (US Patent No.: 7,931,371) teaches an instance wherein the sensor is configured to measure the non-zero residual spherical error (a sensor for sensing errors is disclosed in column 9 lines 50-67 into column 10 lines 1-2, where the error is a spherical and/or cylindrical error in column 10 lines 30-45. If an error is found, said error will be non-zero), and wherein the non-zero residual spherical error comprises a non-zero physical error (as a determination of a cylindrical error is present in column 10 lines 30-45, and as a cylindrical error is indicative of the shape of the cornea of the eye, said cylindrical error determination is a determination of a physical error that is non-zero).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensors of Dai into Zickler in view of Raymond for the purpose of providing a sensor that is able to quantify aberrations throughout the entire optical system of the patient’s eye in column 2 lines 3-15, where the system detailed in column 2 lines 3-15 is a sensing means for spherical error. From here, as said sensors of Dai are used for determining a spherical error, said sensors are also able to determine a residual spherical error as a residual error that is the error still present after corrective measures are taken and, as the sensors are directly imaging the eye in column 10 lines 30-45, said sensors are still able to sense an error after a corrective action is added.
Regarding claim 2, Zickler in view of Raymond and Dai teach the method of claim 1, wherein Zickler discloses that the power addition is a positive diffractive power addition (a low add in power is disclosed in [0058] and [0060].As per [0060] of Zickler, the IOL also includes a mask that includes a diffractive surface that provides a low add in power and as the laser modifies “desired subsurface regions of the intraocular lens” in [0053] of Zickler, Zickler is capable of modifying the diffractive mask via a treatment laser. ) that at least partially reduces a longitudinal chromatic aberration of the eye (treatment of general optical aberrations disclosed in [0043]).
Regarding claim 3, Zickler in view of Raymond and Dai teach the method of claim 1 or 2, wherein applying the plurality of laser pulses comprises applying a plurality of focused laser pulses (focusing optics for focusing a pulsed laser in [0028] of Zickler)
However, Zickler does not teach an applying of laser pulses according to a predetermined pattern to at least one selected area of the IOL to produce the diffractive power addition. It is the examiners position that Zickler inherently applies laser pulses according to a predetermined pattern to at least one selected area of the IOL to produce the diffractive power addition as the laser correction of Zickler is not random (detailed in [0038]). However, Raymond teaches an applying of laser pulses according to a predetermined pattern (applying of lasers in a pattern in [0042] and [0091]) to at least one selected area of the IOL to produce the diffractive power addition (the laser of Raymond can be used to treat an intraocular lens in [0038] or [0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the spherical error characterization of Raymond into Zickler to provide a pre-treatment evaluation of a patient that the controller of Zickler (controller in [0008]-[0010]) can use to control the laser application (use of sensed values for a control in [0052] of Zickler).
Regarding claim 4, Zickler in view of Raymond and Dai teach the method claim 1. However, Zickler does not teach an instance wherein the estimated diffractive power addition fully compensates for a longitudinal chromatic aberration. Instead, Raymond teaches a fully compensating for a longitudinal chromatic aberration (compensation for aberrations that include chromatic adjustments via a “chromatic and co-sign correction module” is disclosed in [0142], where a complete correction of an aberration is present in [0021], where Raymond recites that “after treatment of the patient’s eye the aberrations are substantially eliminated,” which requires the treatment to remove all aberrations in the eye.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the chromatic adjustments present in Raymond into Zickler as said adjustments are used in a with a pre-treatment module to control a treatment. As Zickler teaches a laser for treatment of a lens in [0050]-[0051].
Regarding claim 5, Zickler in view of Raymond and Dai teach the method of claim 1, wherein Zickler discloses that the diffractive power addition is estimated based at least in part on at least one of: estimated IOL power to target emmetropia; subject's axial length; surgeon's optimized A constant; and effective lens position (ELP) (evaluation of a position of a lens (ELP) with respect to a cornea laser modification of an implanted IOL disclosed in [0007]. ELP with respect to an IOL is taken to be the distance between said IOL and a cornea).
From here, Raymond teaches a power addition that is estimated based on at least in part on an estimated IOL power to target emmetropia (targeting emmetropia is disclosed in [0021] of Raymond, estimation of a power required by an IOL in [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an estimation of an IOL power to target emmetropia into the determination of a power addition to said IOL as achieving emmetropia in the patient’s eye, as per [0021] of Raymond, eliminates any refractive errors in a user’s vision, also present in [0021] of Raymond.
Regarding claim 6, Zickler in view of Raymond and Dai teach the method of claim 1, wherein Zickler discloses that the laser pulses are configured and applied to the IOL such that the power addition does not induce further spherical aberration or modify existing spherical aberration (as Zickler discloses a determination of aberrations in [0043]-[0044] for the purpose of correcting them with a laser, Zickler is not intended to induce further aberrations).
From here, Raymond (US Pub No.: 2016/0150952) also does not induce further spherical aberration or modify existing spherical aberration (in [0021], where Raymond recites that “after treatment of the patient’s eye the aberrations are substantially eliminated,” which requires the treatment to remove all aberrations in the eye).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the complete elimination of aberrations via a treatment (being a laser treatment in [0035] of Raymond) into the treatment presented in Zickler as doing so achieves emmetropia in the patient’s eye, as per [0021] of Raymond, thereby eliminating any refractive errors in a user’s vision.
Regarding claim 27, Zickler in view of Raymond and Dai teach the method of claim 1, wherein Zicker teaches the diffractive power addition is implemented through a phase pattern (laser to modify an intraocular lens in a “desired pattern” in [0038]).
Regarding claim 28, Zickler in view of Raymond and Dai teach the method of claim 27, wherein Zickler the phase pattern comprises a total phase addition of up to one lambda (in [0067], a high power add is disclosed to allow for the lens to provide “two or more distinct foci.” A power add would need to provide a phase addition of one lambda to provide two or more distinct foci).
Regarding claim 29, Zickler in view of Raymond and Dai teach the method of claim 27, wherein Zickler the phase pattern comprises at least one zone width calculation (controller to select laser parameters including pulse width in [0031]).
Regarding claim 30, Zickler in view of Raymond and Dai teach the method of claim 29, wherein Zickler discloses the at least one zone width calculation is configured to achieve an appropriate power change and slope (enacting a power change in [0058]-[0059]. While slope is not disclosed here, an effective change in optical power, as disclosed in [0059], would require a slope change).
Regarding claim 31, Zickler in view of Raymond and Dai teach the method of claim 27, wherein Zickler discloses the phase pattern comprises a step height larger than one lambda (in [0067], a high power add is disclosed to allow for the lens to provide “two or more distinct foci.” A power add would need to provide a phase addition of one lambda to provide two or more distinct foci).
Regarding claim 32, Zickler in view of Raymond and Dai teach the method of claim 31, wherein Zickler discloses the phase pattern is configured to achieve a monofocal shift (modification of monofocal lenses in [0029], moving of a focal point of the laser in [0038] that will modify a focal point separation and focal point depth of the lens as per [0046]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zickler (US Pub No.: 2010/0082017) in view of Raymond (US Pub No.: 2016/0150952), Dai (US Patent No.: 7,931,371), and Knox (US Pub No.: 2018/0373060).
Regarding claim 7, Zickler in view of Raymond and Dai teach the method of claim 6. However, said combination does not teach an instance wherein control of the spherical aberration is performed at least in part by changing the phase profile of the IOL by refractive index writing.
Instead, Knox (US Pub No.: 2018/0373060) discloses an instance wherein control of the spherical aberration is performed at least in part by changing the phase profile of the IOL by refractive index writing (in [0039] and [0053], where a wavefront cross-section phase profile is established via a laser machining. The changes in the refractive indices caused by refractive index writing of the lens of the IOL play a part in correcting aberrations of said lens).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of a laser to alter or establish a wavefront cross-section phase profile in an intraocular lens for the purpose of allowing the laser to “vary the refractive index” of materials on an intraocular lens at different regions of the lens, as per [0053]. This allows for the IOL to have multiple regions with different phase profiles (in [0014]-[0015]) which can allow the IOL to have “multifocality” as per [0123], where paragraph [0123] of Knox also discloses that the phase profiles employed are able to correct “native higher order aberration profiles of individuals.”
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zickler (US Pub No.: 2010/0082017) in view of Raymond (US Pub No.: 2016/0150952), Dai (US Patent No.: 7,931,371), Knox (US Pub No.: 2018/0373060) and Serdarevic (US Pub No.: 2019/0060056).
Regarding claim 8, Zickler in view of Raymond, Dai and Knox teach the method of claim 7. However, Zickler does not teach an instance wherein control of the spherical aberration is performed at least in part by changing, by the refractive index writing on the IOL, the size of diffractive profile zones in r2 space.
Instead, Serdarevic (US Pub No.: 2019/0060056) teaches an instance wherein control of the spherical aberration is performed at least in part by changing, by the refractive index writing on the IOL, the size of diffractive profile zones in r2 space (use of a laser to modify the radius of curvature in [0089] with a disclosure of an intraocular lens modification in [0114], where r2 is taken to be the radius of curvature. Modifying a radius of curvature means that the area (and the diameter of a profile zone as the diameter is affected by the radius of curvature, with a 3mm diameter being present with a 7.6mm ROC in [0093]) of the profile zones about the r2 space are also be modified).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a modifying a radius of curvature as presented in Serdarevic into the combination with Zickler for the purpose of providing a means to specifically modify the radius of curvature of an IOL when implanted in the body (as per [0114] of Serdarevic) that can be used to correct problems with an intraocular lens that may arise over time and usage of the lenses, as per [0003] of Serdarevic.
Claim(s) 9 and is/are rejected under 35 U.S.C. 103 as being unpatentable over Zickler (US Pub No.: 2010/0082017) in view of Raymond (US Pub No.: 2016/0150952), Dai (US Patent No.: 7,931,371), Knox (US Pub No.: 2018/0373060), and Wortz (US Pub No.: 2018/0110613).
Regarding claim 9, Zickler in view of Raymond, Dai and Knox teach the method of claim 7. However, Zickler does not teach an instance wherein a phase profile induced in the IOL to correct for residual errors is calculated based at least in part on effective lens position (ELP) measured during the refractive index writing.
Instead, Wortz (US Pub No.: 2018/0110613) discloses an instance wherein a phase profile induced in the IOL to correct for residual errors is calculated based at least in part on effective lens position (ELP) measured during the refractive index writing (Wortz discloses an evaluation of an effective lens position in [0182] and [0187] to determine an error on an intraocular lens. Here, while Wortz does not teach a laser for correcting an error, the ELP determination of Wortz with the laser and controller in the abstract of Zickler can be used in tandem to modify an existing IOL).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the effective lens position determination of Wortz into Zickler in view of Raymond, Dai and Knox Zicklerfor the purpose of providing a means for determining a position of a lens that is disclosed as being “one of the main reasons for this high amount of refractive unpredictability” disclosed in [0182] of Wortz that the device of Zickler can be used to remedy
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Knox (US Pub No.: 2018/0373060) considered for a laser machining to create a phase profile in [0039] and [0053]. Serdarevic (US Pub No.: 2019/0060056) considered for a laser modifying a radius of curvature of a lens in [0089]. Ambati (US Pub No.: 2021/0030531) was considered for laser details used to shape an IOL, like in [0071]. Goldshleger (US Pub No.: 2019/0142576) disclosed for a post-operative modification of a lens in [0022].
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774